Label: HYDROSKIN- hydrocortisone cream
- NDC Code(s): 0536-5108-95
- Packager: Rugby Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated January 15, 2013
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- Active ingredient
- temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
- poison ivy, oak, sumac
- insect bites
- seborrheic dermatitis
- temporarily relieves external anal and genital itching
- other uses of this product should only be under the advice and supervision of a doctor
For external use only
Do not use
- for the treatment of diaper rash. Ask a doctor.
- in the genital area if you have a vaginal discharge. Ask a doctor.
When using this product
- avoid contact with the eyes
- for external anal itching, do not use more than directed. In case of bleeding, consult a doctor promptly
- do not insert cream into the rectum by using fingers or any mechanical device or applicator
Stop use and ask a doctor if
- condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
- for itching of skin irritation, inflammation, and rashes:
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
- children under 2 years of age: do not use, ask a doctor
- for external anal and genital itching, adults:
- when practical, clean the affected area with mild soap and warm water and rinse thoroughly
- gently dry by patting or blotting with toilet tissue or a soft cloth before applying
- apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: ask a doctor
- Other information
- store at 15°-30°C (59°-86°F)
- see box or crimp of tube for lot number and expiration date
- Inactive ingredients
emulsifying wax, glycerin, isopropyl palmitate, lactic acid, purified water, sorbitol solution, Preservative: benzyl alcoholClose
- Questions or comments?
- Principal Display Panel
1% Hydrocortisone Anti-Itch Cream
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-5108 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE 1 g in 100 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) LACTIC ACID (UNII: 33X04XA5AT) SORBITOL (UNII: 506T60A25R) Product Characteristics Color WHITE (Off white) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0536-5108-95 1 in 1 CARTON 1 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 10/29/2012 Labeler - Rugby Laboratories (191427277)